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Senior Quality Control Analyst Lab Support

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.


 


Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.



  • Maintain the network of instruments and client systems per 21 CFR requirements, including but not limited to account management, troubleshooting, training, security, group policies and instrument lifecycle.

  • Maintain data integrity, including but not limited to performing assessments, backup and recovery, periodic reviews and disaster recovery per FDA guidelines and company SOP?s.

  • Write and execute IOQ?s, PQ?s and related documentation for new instrumentation and re-qualification as required for existing instruments according to laboratory needs.



  • Stay current in the field of laboratory instrumentation and data integrity to ensure compliance with company SOPs, Specifications, FDA, GLP, QSR and cGMP regulations.

  • Assist in the building and maintenance of custom queries and reports, including but not limited to using Oracle SQL Developer and Crystal Reports for departmental indicators, trending and charting.

  • Follow continuous improvement practices, including but not limited to QLP, 5S, LEAN, etc.



  • Participate in functional efforts involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.

  • Perform laboratory instrumentation audits as required. Review and update, as required, software administration SOPs.

  • Work within the LIMS system in an administrative role, including but limited to user/role management, troubleshooting issues, assisting end users.

  • Assist analysts in troubleshooting issues via remote connection after business hours as needed and required.



  • May perform other duties as assigned.

    Requirements:




  • Strong technical problem solving skills in the area of regulated 21 CFR laboratory instrumentation and data integrity.

  • Knowledge of laboratory instrumentation and software, including but not limited to Empower, LIMS, Chromeleon and OpenLab.

  • Excellent computer skills, including but not limited to Microsoft Word, Excel PowerPoint and Access. Knowledge of Crystal Reports and SQL Developer a plus.

  • Must be able to read and follow detailed written instructions and have good verbal/written communication skills with supervisors, peers, vendors, and technical support.

  • Ability to handle multiple tasks concurrently, and in a timely fashion.

  • Must demonstrate effectiveness in ability to train others.

  • Availability to the laboratory network via remote connection after business hours as needed and required.

    Qualifications:



Bachelor?s Degree in Information Technology or Chemistry or Biological Sciences with 2-5 years? experience, or Master?s Degree in Chemistry, or Biological Sciences, with 0-3 years? experience.


Appropriate additional certifications may be required pursuant to state or federal regulatory requirements




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